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Clean Room Production -Packager (3Rd Shift)

Expired Job

DJO Global Austin , TX 78719

Posted 5 months ago

Job Description:

DJO Surgical has an immediate opening for a Clean Room Production Packager/Processor located in our Austin, TX manufacturing facility. We are located near 183 and Burnet Road in North Austin.

Summary:

Under minimal supervision this individual this individual is responsible for cleaning, packaging, labeling, and assembling medical devices in accordance with DJO's Quality System. This function is performed in a classified Clean Room; adherence to established environmental requirements is essential. This individual is also responsible for conducting process and product verifications in accordance with DJO's Quality System to meet or exceed requirements of FDA Quality System Regulations (QSR) and other international regulatory standards (ISO, MDD, and CMDR).

Essential Duties and Responsibilities:

  • May be designated as Department Trainers and trains workers in equipment operation and in processing. Should understand the principles, theories, and concepts of GMP, cleaning, and sterilization processes.

  • Work closely with Manufacturing Engineering to disposition non-conforming product and enter Non-Conforming Material Reports (NCMR) when they arise.

  • Visually inspect product for obvious defects, product markings and conformity to engineering drawing and DJO visual standards detailed in Material Specifications (MS) and Inspection Procedures (IP).

  • Verify product size, orientation, configuration, etc. per work order instructions and engineering drawing using templates, calipers, and other basic measuring tools.

  • Visually inspect assembly process of components per established procedures and engineering drawing; use of an optical comparator may be necessary.

  • Final verification and inspection of packaged product per work order Bill of Material (BOM).

  • Verify Hydrogen Peroxide Gas Plasma Sterilization process per work order instructions and established procedures.

  • Conduct Biological Indicator Testing to monitor the HPGP Sterilization process per established procedures.

  • Clean product according to instructions on the work order using applicable procedures or work instructions.

  • Print computer-generated labels and label the product as indicated on the work order using applicable procedures or work instructions.

  • Package product in appropriate material as indicated on the work order using applicable procedures or work instructions.

  • Assemble components per work order instructions, established procedures, and engineering drawing.

  • Maintain Clean Room equipment (i.e. ultrasonic cleaner, shrink wrapper, sealer, etc.).

  • Prepare product for in-house sterilization, transport to contract sterilizer or transport to the Finished Goods warehouse.

  • Perform housekeeping duties as required by established procedures to maintain required levels of cleanroom certification. Duties include (by example and not exclusion) mopping/sweeping floors, wiping work surfaces, and trash disposal.

  • Accurately complete Device History Record and associated paperwork.

  • Conduct Document Review and Release of non-sterile product.

  • Maintain and update production and material control systems (ERP) as needed to ensure proper job and material tracking is maintained.

  • Performs other duties as assigned by Clean Room Lead or Manufacturing Supervisor.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

  • Design
  • Demonstrates attention to detail.
  • Problem Solving
  • Identifies and resolves problems in a timely manner; uses reason even when dealing with emotional topics.
  • Technical Skills
  • Assesses own strengths and weaknesses; strives to continuously build knowledge and skills; shares expertise with others.
  • Oral Communication
  • Listens and gets clarification.
  • Team Work
  • Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed.
  • Written Communication
  • Writes clearly and informatively; able to read and interpret written information.
  • Diversity
  • Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.
  • Attendance/Punctuality
  • Is consistently at work and on time.
  • Dependability
  • Follows instructions, responds to management direction; takes responsibility for own actions.
  • Planning/Organizing
  • Uses time efficiently.
  • Quality
  • Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; Applies feedback to improve performance; monitors own work to ensure quality.
  • Quantity
  • Meets productivity standards; completes work in timely manner; strives to increase productivity; works quickly.
  • Safety and Security
  • Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properly.
  • Demonstrates commitment to the DJO Compliance & Ethics Program, the DJO Code of Conduct, the DJO Sales and Marketing Code of Conduct, the AdvaMed Code of Ethics, and all supporting and applicable regulations, policies and procedures.

  • Demonstrates commitment to the DJO Values, Mission and Vision.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

  • High school diploma or general education degree (GED);

  • 2+ years related experience.

  • Familiar with component engineering drawings (blue prints).

  • Knowledge of GMP/QSR and ISO standards.

  • Experience in a manufacturing environment.

Language Ability:

  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions or manuals, procedures and work instructions.

Math Ability:

  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

PLEASE NOTE: THIS IS FOR 2nd SHIFT ONLY. TEMP TO PERM POSITION.

Relocation is not available. You must state your hourly requirements in order to be considered.

Education/Experience:

  • High school diploma or general education degree (GED);

  • Familiar with component engineering drawings (blue prints).

  • Knowledge of GMP/QSR and ISO standards.

  • Experience in a manufacturing environment.

ABOUT DJO GLOBAL

DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. Our products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of our medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast, Chattanooga, CMF, Compex, DonJoy, ProCare, Exos, Dr. Comfort, DonJoy Performance and DJO Surgical.

For additional information on the Company, please visit www.DJOglobal.com.

DJO is a portfolio company of the Blackstone Group

EOE AA M/F/VET/Disability

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.


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Clean Room Production -Packager (3Rd Shift)

Expired Job

DJO Global